Online Webinar 2019 - Live Webinar 60 minutes Environmental Monitoring Investigations

Overview
This webinar will provide an overview of environmental monitoring investigations and tools to complete an investigation. Environmental monitoring is the method by which clean rooms are known to maintain a certain level of cleanliness. The methods by which clean rooms are monitored are through viable and non-viable testing. Through this testing, a room may demonstrate that it is out of control. This seminar will provide aspects to investigate and determine a root cause, as well as, appropriate actions to complete the report.
Why should you attend
Understanding how your clean room operates is the key to getting through an inspection. An inspector with expect you to conduct a comprehensive report and put the proper actions into place. This webinar will provide the tools necessary to have that comprehensive report the inspector is looking for and provide appropriate corrective actions for the various excursion types.
Session Highlights
International regulations (ISO)
Federal regulation (FDA, USP)
Non-viable testing
Possible sources
Viable testing
Identification of microorganisms
Possible sources
Determination of a root cause
Corrective and Preventative actions to put into place
LEARNING OBJECTIVES
Provide background information on regulatory guidance on environmental monitoring.
Provide background information on environmental monitoring methods for viable and non-viable testing.
Correlate non-viable and viable results with the appropriate environmental monitoring controls.
Provide possible sources of contamination and possible corrective actions.
Provide possible preventative actions in order to prevent future contamination
Provide case studies on contamination events.
Who will benefit
Pharmaceutical Manufacturing Companies
Contract Manufacturing Companies (CMOs)
Personnel Involved with Environmental Monitoring Operations
Speaker Profile
Years of Experience: 29+ years
Areas of Expertise: Biology, Microbiology, and Biochemistry
Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance Professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However, his avid interest in biology, microbiology, and biochemistry officially began when he served in the U.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse.
Carl holds various degrees and certifications, includingan M.S. in Biomedical Quality Systems from San Diego State University, a B.S. in Microbiology from the University of Texas, and Specialized Certificates in QA/QC & Biotechnology from UCSD.